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MasterControl/Datafarm GxP2eCTD Connector - eCTD Assembly Software

Software System to Help Automate the eCTD Assembly Process

Regulatory agencies worldwide are increasingly recognizing the substantial efficiencies that can be achieved by reviewing electronic submissions and the significant reductions in cost and storage that come from replacing paper submissions. The electronic document and submission revolution is underway and your company can compete and thrive in the market by embracing the new initiatives. The original standards established by the International Conference on Harmonisation (ICH) are evolving, which makes the adoption, introduction, and maintenance of these standards into your regulatory operations more imperative to ensure your ability to deliver compliant applications.

Implementing a document management system streamlines document processes but it is recognized that the submissions process in typical regulatory environments is usually disconnected from the document source. To offset the resulting process inefficiencies that are inevitably introduced, MasterControl Inc. and Datafarm Inc. offer an integrated collaboration product that connects the MasterControl GxP process management solution suite with the S-Cubed® (Smart Submission Solutions) and a-Pulse document publishing tools. The connector allows users to readily locate, work with, and add documents to the eCTD submission, maintaining full integrity and compliance of your submission, all within MasterControl’s secure document repository. The MasterControl Submissions Locker™ collaborates seamlessly with the S-Cubed® eCTD submission assembly tool to maintain the integrity of PDF files, the FDA’s required file format for electronic regulatory submissions.

How Can the MasterControl/Datafarm GxP2eCTD Connector Help You?

MasterControl Deviations automates and manages the process of documenting, investigating, and resolving operational deviations from written procedures and specifications. This solution provides the capability to resolve a deviation efficiently and to use data collected as a basis for continuous quality improvement.

Here's how MasterControl addresses some of the major challenges that companies face when resolving deviations.

Connected eCTD Assembly Processes As changes are made to documents during a submission’s lifecycle it is imperative that there is adequate control and notification to all associated. The GxP2eCTD connector provides a seamless process and delivers consistent communication to preserve the integrity of the documents throughout each stage of development.

Inefficient ProcessModifying document properties in disconnected systems wastes time, effort, and resources and can often lead to the inclusion of incorrect information at the time of validation.

Efficient, Automated Process Since documents are susceptible to constant change during the development stage, the GxP2eCTD connector enables immediate notification to all those contributing to the submission development. The MasterControl system retains the security and protection of the document attributes. Authorized changes automatically instigate revalidation in the Datafarm electronic submission process.

Substandard Systems A common reason for the FDA to give a “refusal to file” (RTF) notice is that the PDF documents included in regulatory submissions do not meet basic requirements. Systems that are not interoperable are often the root of companies’ inability to maintain the integrity of PDF documents.

Exceptional SystemsEvery possible control and security measure is provided by the MasterControl system. The GxP2eCTD connector links the secure documents to the Datafarm S-Cubed® eCTD application to ensure the documents are fully compliant with the agency requirements prior to submission. This makes certain that submission integrity is maintained and the final deliverable is fully compliant.

Summary of Features

The MasterControl and Datafarm GxP2eCTD Connector provides a bridge between the management and control of your documents and a compliant eCTD publishing and assembly solution. The GxP2eCTD product brings together the combined capabilities of two powerful solutions which enables users to take full control in managing documents from conception in R&D, through the review/approval stage, throughout submission compilation and registration, and into managing the full life cycle and archiving of applications. Features and benefits of the GxP2eCTD Connector include:

Author Ownership - Connecting Datafarm technology with MasterControl’s renowned document management and control capabilities means that authors will be able to “author” submissions documents in the system from start to finish during the entire submissions document lifecycle. The collaboration offers role-based security and submission management, which allows users to be in complete control of the process stage and restrict access as necessary.

Template Management - The process typically starts with content creation during the R&D stage of the drug development process. Problems unavoidably arise when many different formats are in use. The time-consuming task of reformatting for compliance purposes inevitably occurs at the most time-critical phase of the submission stage. Datafarm’s S-Cubed Templates is a collection of pre-defined formats covering over 200 document templates based on the eCTD module 1 to 5 and Clinical Trial Applications structure. These templates provide authors with a compliant, easy to use, format for entering content. Access to the templates for maintenance or use can be controlled through the MasterControl document management system ensuring that no unauthorized changes are introduced.

Document Compliance - The GxP2eCTD product facilitates the access for content creation, review, and approval using the MasterControl document management system. With Datafarm S-Cubed® Templates integrated with the MasterControl document management system, users are assured that document formats will remain compliant and users will have an easy to use format for entering all the data relating to applicable projects. This saves significant time otherwise wasted on re-formatting during the submission process. In addition, documents retain their compliance through to the submission stage without significant rework and extensive time-consuming publishing. MasterControl and Datafarm’s solutions are fully compliant with FDA 21 CFR Part 11 requirements.

Collaboration and Document Integrity - As content is developed, significant time and resources can be saved by automatically notifying applicable users that documents are ready for review or approval. MasterControl provides a secure and proactive method to ensure efficient collaboration between users and guarantees that procedures are executed in a timely manner. This provides users with a broad range of capabilities, including: virtual collaboration, automatic routing, revision control, automated escalation, and electronic approval of submissions documents. The GxP2eCTD product further progresses the process by initiating the Datafarm publishing and submission compilation. By uniting Datafarm’s submissions publishing tools with a connected MasterControl system, regulatory departments can be assured that document integrity is maintained, including bookmarks and hyperlinks. Datafarm’s products conform to all current eCTD guideline stipulations and are RPS ready.

PDF Publishing Capabilities - Combining the MasterControl and Datafarm products through the GxP2eCTD products empowers users to take control of documents and extend their effectiveness throughout the submission process. The seamless process provided by the GxP2eCTD Connector allows users to readily convert documents to PDFs and create links and bookmarks to meet the requirements of regulatory agencies. Where paper submissions are required, the Datafarm products will: allow for the pagination of documents; add headers, footers, and watermarks to documents; split and merge PDFs; insert pages before or after a page; remap broken bookmarks and links; lock documents during editing to prevent other users from making changes; create links without losing focus on source document; add internal and external bookmarks; create cross links and bookmarks with one click; and permit modification and review of existing link/bookmark properties. Datafarm’s products provide PDF publishing functionalities and navigational tools not available in Adobe® Acrobat®, which makes the PDF publishing process more simple, rapid, and accurate.

Publishing Security and Archiving - Datafarm products can be utilized for the final linking and proofing of documents, assembly of the electronic regulatory submission, and management of the submission throughout its lifecycle, all of which is maintained within and kept secure by the MasterControl system. Completed submissions need to be fully locked once accepted by the agency and MasterControl’s repository management functions ensure that all documents associated with the submission are securely archived with limited access except for review. The GxP2eCTD product adopts all the security features of MasterControl. When submission sequences are being developed in the Datafarm products, users will have full access to the submission history without compromising the security of archived data.

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The QMS Provider for the FDA

MasterControl Inc. and its partner company, i4DM, have been the QMS providers for the FDA’s Office of Regulatory Affairs (ORA) since 2009. The FDA recently expanded its implementation of MasterControl’s Quality Excellence™ solutions to improve the quality and audit management processes of the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).